Zosano Pharma to showcase new post-hoc analyses of Qtrypta’s (M207) clinical trial data comparing key efficacy results from...
June 13 2020 - 6:00AM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced that new post-hoc
efficacy analyses of QtryptaTM, Zosano’s lead investigational
product candidate for the acute treatment of migraine, will be
presented as a virtual oral presentation on the 2020 American
Headache Society’s Virtual Annual Scientific Meeting Platform.
Six different measurements of pain reduction from the
exploratory efficacy results in the long-term safety study (“LTSS”)
were examined and compared to the positive clinical results
observed in the Phase 2/3 Zotrip study. Across all six
efficacy measurements, which included pain freedom and pain relief
at 2 hours, clinical activity observed in the LTSS during the
one-year trial period treating approximately 6,000 attacks was
consistent with the positive pivotal study results.
Parameter |
ZOTRIP (Single Dose) |
Open-Label |
Long-Term |
Placebo |
M207 3.8 mg |
M207 3.8 mg |
(n = 77) |
(n = 82) |
(5,617 migraine attacks*) |
Pain Freedom at 2 hours |
14% |
42% |
44% |
Pain Relief at 2 hours |
57% |
81% |
81% |
Sustained Pain Freedom 2-24 hour |
10% |
32% |
38% |
Sustained Pain Freedom 2-48 hour |
9% |
27% |
35% |
Sustained Pain Relief 2-24 hour |
38% |
68% |
70% |
Sustained Pain Relief 2-48 hour |
33% |
63% |
65% |
* For sustained endpoints, data from all timepoints
2-24 (48) hours had to be present |
Similar to the pivotal study, the most common adverse events
observed in the LTSS were redness and swelling at the application
site, of which more than 95% were classified as mild. 80% of these
site reactions were generally resolved within 48 hours. Patients
treated with Qtrypta reported less triptan-like neurological side
effects than are typically found with the class, with less than 2%
of patients in the LTSS reporting effects such as dizziness and
paresthesia.
“Migraine is a painful and debilitating neurologic disease
impacting over 34 million people in the US. The post-hoc analyses
suggest that Qtrypta’s efficacy results across approximately 6000
attacks treated in the LTSS were consistent with the positive
results seen in the pivotal Zotrip study,“ said Egilius Spierings,
MD, Founder, Medical Director, and Principal Investigator Medvadis
Research Director, Boston Headache Institute at Boston PainCare. “I
believe that Qtrypta, if approved, has the potential to be a
promising and innovative option for migraine patients.”
“As we continue to learn about the profile of our unique
investigational product being developed as a potential treatment
for headache disorders, we remain committed to sharing this
information with the scientific community,” said Dr. Don Kellerman,
Vice President of Clinical Development and Medical Affairs at
Zosano.
About Qtrypta™ (M207)
Qtrypta is Zosano’s proprietary formulation of zolmitriptan
delivered utilizing its proprietary intracutaneous microneedle
system (the “System”) in development for the acute treatment of
migraine. The System consists of titanium microneedles
coated with drug, and in the case of Qtrypta™, the formulation is
zolmitriptan. The drug-coated microneedles are designed to
penetrate the stratum corneum, where the investigational drug
dissolves and easily enters into the bloodstream. In February 2017,
the Company announced statistically significant results from the
ZOTRIP pivotal study, in which the 3.8 mg dose of Qtrypta™ met both
co-primary endpoints, achieving pain freedom and most bothersome
symptom freedom at 2 hours.
About Migraine
Migraine is a highly prevalent neurological disease impacting
12% of the US population and 1 in 4 households. Patients impacted
by migraine experience significant disability, with 90% unable to
function normally. Migraine attacks are estimated to lead to
lost productivity costs as high as $36 billion annually in the
United States, including both direct and indirect costs. There is a
significant need for new acute treatment options since 74% of
migraine patients experience inadequate treatment response.
About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage biopharmaceutical
company focused on developing products where rapid administration
of approved molecules with established safety and efficacy profiles
may provide substantial benefit to patients, in markets where
patients remain underserved by existing therapies. The company’s
intracutaneous microneedle system technology consists of titanium
microneedles coated with drug that are designed to enable rapid
systemic administration of therapeutics to patients. Zosano’s lead
product candidate is Qtrypta™ (M207), which is a proprietary
formulation of zolmitriptan delivered via its intracutaneous
microneedle system technology, as an acute treatment for migraine.
The company anticipates that many of its current and future
development programs may enable the company to utilize a regulatory
pathway that has the potential to streamline clinical development
and accelerate the path towards commercialization.
Forward-Looking Statements
This press release contains forward-looking statements regarding
the presentation of post-hoc analyses of Qtrypta’s (M207) clinical
trial data on the 2020 American Headache Society’s Virtual Annual
Scientific Meeting Platform, the potential benefits of Qtrypta for
patients and other future events and expectations described in this
press release. Readers are urged to consider statements that
include the words "may," "will," "would," "could," "should,"
"might," "believes," "estimates," "projects," "potential,"
"expects," "plans," "anticipates," "intends," "continues,"
"forecast," "designed," "goal," "unaudited," "approximately" or the
negative of those words or other comparable words to be uncertain
and forward-looking. These statements are subject to risks and
uncertainties that are difficult to predict, and actual outcomes
may differ materially. These include risks and uncertainties,
without limitation, associated with the Company’s ability to obtain
additional cash resources to continue operations for the remainder
of 2020, the process of discovering, developing and commercializing
products that are safe and effective for use as human therapeutics,
risks inherent in the effort to build a business around such
products and other risks and uncertainties described under the
heading "Risk Factors" in the Company's most recent annual report
on Form 10-K and quarterly reports on Form 10-Q. Although Zosano
believes that the expectations reflected in these forward-looking
statements are reasonable, Zosano cannot in any way guarantee that
the future results, level of activity, performance or events and
circumstances reflected in forward-looking statements will be
achieved or occur. All forward-looking statements are based on
information currently available to Zosano and Zosano assumes no
obligation to update any such forward-looking statements.
Zosano Contact:Christine MatthewsChief
Financial Officer(510) 745-1200
PR Contacts:Sylvia Wheeler or Alexandra
Santosswheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
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